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Neoxidina Alcolica Incolore
Medical/Surgical product for intact skin based on Chlorhexidine gluconate.
Ready-to-use alcoholic solution for EXTERNAL USE
Technical Information
1. Composition
care units, ambulances, diagnosis clinics and others,
for antisepsis of:
100g of solution contains:
Active ingredient:
Chlorhexidine gluconate
Ethyl alcohol 95°
Excipients:
Denaturing agents of ethyl alcohol
(isopropyl alcohol and acetone),
co-formulants, purified water
0.5g
66.29g
a. the intact skin of a patient before surgery or other
invasive operations;
b. the hands of healthcare personnel for the carrying out
of antiseptic procedures, after contact with infected
material and in preparation for surgery.
The product must be used as it is, without dilution.
up to 100g
2. Product characteristics
Neoxidina Alcolica Incolore is a ready-to-use
alcoholic solution for antisepsis of intact skin and hands.
Contains chlorhexidine gluconate and ethyl alcohol.
Works immediately and remains effective over time.
The recent guidelines from the American CDC
recommend the use of alcoholic solutions for social
and surgical antisepsis of hands, since the use of such
products, rather than antiseptic soaps, does not require
water and is simple and fast.
3. Range of application
and instructions for use
Neoxidina Alcolica Incolore is highly practical to
use, since it does not require water for either washing or
rinsing. Antisepsis of skin and hands may, therefore, be
carried out everywhere, with no need for sponges
or water.
Neoxidina Alcolica Incolore may be used in all
departments where hygiene is important, such as, for
example, hospital wards, operating theatres, intensive
a. Antisepsis of intact skin of a patient: soak a sterile
swab and apply to the area to be treated, scrub
vigorously for at least two minutes.
b. Antisepsis of hands prior to surgery:
napply 6ml (3 presses of the 2 cc dispenser pump)
of solution to the hands and forearms;
n scrub vigorously for at least 1 min. 30 sec.
until completely dry;
n repeat the operation a second time
(total 3 minutes).
c. Antisepsis of the hands of healthcare personnel on
the ward:
napply 4ml (2 presses of the 2 cc dispenser pump) of
solution over the hands and wrists;
n scrub vigorously for at least 30 sec. and wait
until completely dry;
It should be noted that, before starting antisepsis on
the hands, or afterwards if hands are visibly dirty,
it will be necessary to wash them with an antiseptic
detergent solution.
Warning: Neoxidina Alcolica Incolore may
cause chemical burns to newborns, especially
if born prematurely. Use with caution.
INFORMATION RESERVED FOR HEALTH CARE PROFESSIONALS AND PROFESSIONAL USERS
NEOXIDINA ALCOLICA INCOLORE
TECHNICAL INFORMATION 2 of 2
4. Microbiological activity
Neoxidina Alcolica Incolore is a chlorhexidine
gluconate and ethyl alcohol-based solution.
Chlorhexidine gluconate is particularly effective against
gram-positive bacteria, yeasts and viruses. It works
through inactivation of the fundamental enzymatic
systems of the cell wall, initial disorganisation of the
cytoplasmic membrane, modification of the permeability
and consequent loss of cell material. The ethyl alcohol
causes coagulation phenomena that damage the
proteins, following the demolition of the hydration ring
that surrounds the protein molecules that make up the
protoplasm and keeps them in suspension.
As shown by specific studies on biocidal activity,
Neoxidina Alcolica Incolore effectively reduces
resident and transient bacterial flora on the skin.
The solution has bactericidal (gram + and gram -),
yeasticidal (Candida albicans) and virucidal activity.
The following tables summarise the biocidal efficacy
data of Neoxidina Alcolica Incolore.
Specific strain
Reduction
Gram + bacteria
Staphylococcus
aureus ATCC 6538
> 105
Gram – bacteria
Pseudomonas
aeruginosa
ATCC 15442
> 105
Table 2: Bactericidal activity in suspension for hygienic
and surgical handrub and handwash (prEN 12054) Contact time = 30 seconds
Group of microorganisms
Specific strain
Reduction
Gram + bacteria
Enterococcus hirae
ATCC 10541
> 104
Gram + bacteria
Staphylococcus
aureus ATCC 6538
> 104
Gram – bacteria
Escherichia coli K12
NCTC 10538
> 104
Gram – bacteria
Pseudomonas
aeruginosa ATCC
15442
> 104
Table 3: Hygienic handrub in conditions simulating
practical use (EN 1500) - Contact time = 30 seconds.
Gram – bacteria
Specific strain
Reduction
Yeasts
Candida albicans
ATCC 10231
> 104
Table 5: Virucidal activity (EN 14476) Contact time = 1 minute
Group of microorganisms
Specific strain
Reduction
Viruses
Poliovirus,
Adenovirus
> 104
A study has also been carried out to assess the action
of Neoxidina Alcolica Incolore for surgical hand
disinfection under the conditions laid down by European
standard EN 12791:2005: the product satisfies the
requirements of the standard with a rubbing time
of 1.5 min + 1.5 min (total 3 minutes).
5. Packaging
Group of microorganisms
Group of microorganisms
Group of microorganisms
Specific strain
Average
logarithmic
reduction
Escherichia coli K12
NCTC 10538
Greater than
the product
used as a
reference
Bottle
48 x 100ml + spray 24 x 250ml + spray 24 x 250ml 20 x 500ml 12 x 1L ref. PF06942
ref. PF06941
ref. PF06934
ref. PF06987
ref. PF06986
6. Quality control
The components (raw materials, containers, labels etc.)
and production steps of each individual batch are carefully
controlled in compliance with the SOP (Standard Operative
Procedures) required by standard UNI EN ISO 9001 and
Good Manufacturing Practices.
7. Storage and stability
The product is highly flammable.
Keep the bottle properly closed and away from flames,
sparks and any heat source. Do not smoke. Keep out of
reach of children.
Neoxidina Alcolica Incolore in the original sealed
packaging has a validity of 36 months.
intact skin
Table 1: Basic bactericidal activity (EN 1040) Contact time = 30 seconds.
Table 4: Basic yeasticidal activity (EN 1275) Contact time = 30 seconds
If the package is correctly opened and closed at the end
of each disinfection operation, without contamination
of the residual part, the product maintains its chemicalphysical and microbiological characteristics for 90 days.
Store below +30°C.
8. Regulatory references
Holder of the registration:
Nuova Farmec S.r.l. – Via Flemming, 7
37026 Settimo di Pescantina (VR) – Italy.
Presidio Medico Chirurgico authorized by Italian Ministry
of Health registration N. 16596.
INFORMATION RESERVED FOR HEALTH CARE PROFESSIONALS AND PROFESSIONAL USERS
USF Healthcare S.A. | Rue François Perréard 4 | CH-1225 Chêne Bourg | Geneva | Switzerland
Tel + 41 22 839 79 00 | Fax + 41 22 839 79 10 | [email protected]
www.usfhealthcare.com
11/2015 - A